期刊
CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS
卷 99, 期 3, 页码 754-762出版社
WILEY
DOI: 10.1002/ccd.30014
关键词
balloon angioplasty; drug coated balloon; drug eluting stent; in-stent restenosis
资金
- Boston Scientific Corporation
In patients with drug-eluting stent restenosis, angioplasty with a novel paclitaxel-coated balloon (PCB) with citrate-based excipient was non-inferior to PCB with iopromide excipient in terms of angiographic outcome.
Objectives We investigated the clinical efficacy of a paclitaxel-coated balloon (PCB) with a novel matrix coating and reduced drug concentration in comparison with a widely used PCB with iopromide excipient. Methods We prospectively enrolled patients with restenosis in drug-eluting stents. All patients were treated with a novel low-dose PCB with citrate-based excipient (Agent PCB). Angiographic follow-up was scheduled at 6-8 months. Outcomes were compared against those of patients treated with iopromide excipient PCB (SeQuent Please PCB) enrolled in a trial with identical inclusion and exclusion criteria. The primary endpoint was percent diameter stenosis (%DS) at follow-up angiography. The primary hypothesis was that the investigational device would be non-inferior to the control device ( Identifier: NCT02367495). Results One hundred twenty-five patients with 151 lesions were enrolled. Mean age was 68.1 +/- 10.2 years, 40.8% had diabetes mellitus and 80.1% had focal morphology in-stent restenosis. Follow-up angiography data at 6-8 months was available for 102 (81.6%) patients. The Agent PCB was non-inferior to the SeQuent Please PCB in terms of the primary endpoint (38.9 +/- 17.5 vs. 38.1 +/- 21.5%; p (non-inferiority) = 0.0056). Late lumen loss was also comparable between the groups (0.35 +/- 0.55 vs. 0.37 +/- 0.59; p = 0.71). There was no difference between the groups in the incidence of TLR (27.7% vs. 22.1%; p = 0.31), death or myocardial infarction (4.2% vs. 4.4%; p = 0.92) or target lesion thrombosis (1.0% vs. 0.7%; p = 0.93). Conclusion In patients with DES restenosis, angioplasty with a novel PCB with citrate-based excipient was non-inferior to PCB with iopromide excipient in terms of angiographic outcome.
作者
我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。
推荐
暂无数据